Mindfulness-Based Therapy for Insomnia for Down Syndrome
(SleepDS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byCaroline G Richter, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Trial Summary

What is the purpose of this trial?

Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS). The investigators will work closely with a community advisory board consisting of individuals with DS, their caregivers, and clinicians specializing in DS and sleep medicine to ensure that the intervention protocol is relevant and appropriate for young people with DS (age 12 and older). Planned adaptations include 1) utilization of visual aids and videos to increase engagement and reinforce mindfulness concepts and practices; 2) shortened meditation practices to accommodate concentration limits of individuals with DS; 3) caregiver involvement reflecting the important role of caregivers in daily functioning of individuals with DS; 4) adapted homework to cater to the learning styles of individuals with DS; 5) daily reminders to encourage regular practice and reinforce the importance of consistency; and 6) modified session structure to ensure that participants are able to discuss their experiences and refine their mindfulness practice. During the first 6 months of the project, the investigators will meet monthly with the community advisory board and use an iterative process to develop detailed intervention protocol for a virtual MBTI suitable for young people with DS. Aim 2 of the project will be to pilot test the efficacy of the virtual MBTI for young people with DS. In the second half of the one-year project, the investigators will conduct a pilot randomized clinical trial (RCT) of the intervention developed in Aim 1. This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) for young people with Down syndrome (DS). The interventions will be compared on their impact on improving sleep problems, quality of life, and functional outcomes. This project will also test if targeting the sleep of the caregiver in addition to the individual with Down syndrome has any effect on the outcomes.

Research Team

Caroline G Richter, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for young individuals aged 12 and older with Down syndrome who experience sleep problems. Caregivers will also be involved in the therapy process. Participants must have a stable living situation and internet access for virtual sessions.

Inclusion Criteria

I have been diagnosed with Down syndrome.

I experience sleep problems most nights, as noted by someone who cares for me.

Nonverbal mental age of at least 36 months, as determined by a baseline measure of adaptive skills

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Exclusion Criteria

Inability to complete assessments or participate in the intervention sessions due to behavioral or medical conditions

I am not currently participating in any other sleep or behavioral studies.

Caregiver inability or unwillingness to provide accurate reports or assist in intervention activities as needed

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Treatment Details

Interventions

Mindfulness-Based Therapy for Insomnia (Behavioural Intervention)

Trial OverviewThe study tests an adapted Mindfulness-Based Therapy for Insomnia (MBTI) against a control group on wait-list to see if it improves sleep quality, life quality, and daily functioning in those with Down syndrome.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mindfulness-Based Therapy for InsomniaExperimental Treatment1 Intervention

Individuals with Down syndrome will receive the MBTI intervention over 8 sessions lasting 1 hour over 8 weeks (one session per week). One trained graduate research assistant will deliver the intervention with supervision of a licensed Clinical Psychologist.

Group II: Wait-list controlPlacebo Group1 Intervention

The control group will do the pre and post assessments but will not be part of any intervention. The wait-list control group will receive the MBTI intervention after the post-intervention measures are completed.